Aortic valve regurgitation
Conditions
Interventions
1:TAVI
2:SAVR
Sponsors
West China School of Medicine/West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. aged at least 60 years with heart function grade of NYHA II - IV; 2. Aortic regurgitation (above moderate level) with definite clinical symptoms; 3. Euroscore>12 or STS risk score>4; 4. All the implanted valves in TAVI group are J-valve interventional heart valves and those in SAVR group are artificial biological valves.
Exclusion criteria
Exclusion criteria: (1) Aortic disease complicated by infective endocarditis or other active infections; (2) Aortic disease complicated by severe mitral valve disease; (3) Patients need to undergo operation on great artery; (4) Diameter of annulus >29mm or <18mm in TAVI group; (5) Hypocoagulation, severe hemorrhagic tendency, prohibited anticoagulation therapy or anticoagulation taboo; (6) Onset of TIA or severe stroke or severe dementia within 6 months; (7) Myocardial infarction within a month; (8) Left ventricular thrombus, excrescence or left ventricular outflow tract obstruction; (9) Instable hemodynamics, requirement of large amounts of myocardial contractile force drug or mechanical cardiac assist; (10) Hypertrophic cardiomyopathy; (11) Severe pulmonary arterial hypertension or right ventricular insufficiency; (12) Serious disease with life expectancy less than 1 year; (13) Contradiction of MRI: Absolute contraindications are aneurysm clips, carotid artery vascular clamp, neurostimulator devices, Insulin or infusion pump, implanted drug infusion device, bone growth/fusion stimulator, and ocular foreign bodies(i.e., metal shavings). Relative contraindications are severe claustrophobia, life threatening severe arrhythmias.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Age;Sex;BMI;Body surface area;Systolic pressure;Diastolic pressure;Heart rate;Average size of valves for replacement;STS score;EuroScore;NYHA class;coronary artery disease;Previous PCI;Previous CABG;Previous myocardial infarction;Hyperlipemia;Diabetes mellitus;Hypertension;Chronic kidney disease;Atrial fibrillation;Previous stroke or TIA;Peripheral vascular disease;COPD;Re-operation;Pulmonary arterial hypertension;BNP;hs-TNT;CK-MB;Time of CMR after operation;Specific type of valve;Concomitant surgery;Time of extracorporeal circulation;Blocking time;Length of stay in ICU;Length of stay in hospital;Death;Loss to follow-up;Permanant pacemaker implantation;Valvoplasty;Drug therapy;Cerebral infarction;Other complications;LVEDVI;LVESVI;LVESVI;LVEF;LVM;LVMI;LVM/LVEDV;RVEDVI;RVESVI;RVSVI;RVEF;RVM;RVMI;RVM/RVEDV;LAVol max;LAVol min;Left atrial area under two-chamber view;Left atrial area under four-chamber view;L(shorter length of the two diameters;RAVol max;RAVol min;Mean reverse-flow transvalvular pressure difference;AR fraction;TAPSE;MR fraction;Ascending aortic max lumen area;Ascending aortic min lumen area;Descending aortic max lumen area;Descending aortic min lumen area;Aortic pulse wave;LGE-focal fibrosis mass;LGE-focal fibrosis percentage;LGE-focal fibrosis segment;LGE-scar mass;LGE-scar percentage;LGE-scar segment;Global peak systolic longitudinal strain(GPSLS);Peak systolic longitudinal strain(PSLS);Global peak systolic radial strain(GPSRS);Peak systolic radial strain(PSRS);Global peak systolic circumferencial strain(GPSCS);Peak systolic circumferencial strain(PSCS);Global peak early-diastolic longitudinal strain(GPEDLS);Peak early-diastolic longitudinal strain(PEDLS);Global peak early-diastolic radial strain(GPEDRS);Peak early-diastolic radial strain(PEDRS);Global peak early-diastolic circumferencial strain(GPEDCS);Peak early-diastolic circumferencial strain(PEDCS);Global peak late-diastolic longitudinal strain(GPLDLS);Peak late-diastolic longitudinal strain(PLDLS | — |
Countries
China
Contacts
Public ContactGuo Yingqiang
West China Hospital, Sichuan University
Outcome results
None listed